Kornimate/medical-research-clean huggingface dataset:
comparison of silicone-covered metallic ureteral stent and double-j stent for malignant ureteral obstruction

Conditions: Malignant Ureteral Obstruction

Summary: malignant ureteral obstruction often necessitates chronic urinary diversion and is associated with high rates of failure with traditional double-j ureteral stents. to overcome drawbacks of the double-j stent, recently, metallic stents have been used to manage for palliative treatment in patients with ureteral obstruction associated with end stage malignant disease. the success rates of metallic stents have been reported to be high and the method proved to be useful in patients with malignant ureteral obstruction. in addition, covered metallic stents have many advantages compared with bare metallic stents, such as lower rate of tissue invasion and higher patency rate. however, there is little investigation about comparison of clinical efficacy between covered-metallic stents and double-j stents in malignant ureteral obstruction. therefore, investigators plan to perform a prospective randomized study to compare clinical efficacy of silicone-covered metallic ureteral stent and double-j ureteral stent in patients with malignant ureteral obstruction.


Eligibility criteria:
inclusion criteria: 1. age 20-80 years 2. malignant mid- to distal ureteral obstruction by abdominal or pelvic malignancy with overt hydronephrosis documented on ct scans 3. expected life expectancy more than three months exclusion criteria: 1. history of unilateral nephrectomy or bladder reconstruction 2. history of kidney transplantation 3. history of severe allergy to contrast media 4. state of dialysis 5. performance status - 3 or 4 on ecog scale

Keywords: malignant ureteral obstruction silicone-covered metallic ureteral stent double-j stent
effect of modified mirror therapy in patients with upper limb hemiparesis after stroke

Conditions: Stroke

Summary: this was a randomized controlled study in china conducted during aug. 2022 to aug. 2023. totally, patients with upper limb hemiplegia after stroke, who were admitted in the department of rehabilitation medicine of two hospitals, were enrolled. the study lasted 30 days for each participant. the patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. additionally, the patients in the experimental group were given modified mirror therapy.

upper limb hemiparesis is a motor and sensory disorder that occurs after stroke, with an incidence rate of up to 55% to 75%. effective upper limb rehabilitation methods help reduce the occurrence of disuse syndrome and complex regional pain syndrome. therefore, finding active and effective limb rehabilitation methods has important practical significance.this was a randomized controlled study in china conducted during aug. 2022 to aug. 2023. totally, patients with upper limb hemiplegia after stroke, who were admitted in the department of rehabilitation medicine of two hospitals, were enrolled. the study lasted 30 days for each participant. the patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. additionally, the patients in the experimental group were given modified mirror therapy. the assessment was conducted respectively on day 1 and day 30.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria of stroke, by ct or mri. * the first-onset stroke. * presenting with unilateral upper limb dysfunction, within brunnstrom stage ⅱ to ⅳ on the affected side, and ash-worth score ≤2. * no obvious cognitive impairment, with mini-mental state examination (mmse) score \>21 points. * national institutes of health stroke scale (nihss) score \>4 points. * stable vital signs, no severe diseases such as cancer, liver or kidney disorders. * aged 35-70 years. * courses of diseases 2-6 weeks. exclusion criteria: * presence of aphasia, apraxia, or hemispatial neglect. * presence of hearing, vision, or comprehension impairments that hinder diagnosis and treatment. * complicate with traumas, fractures, or other progressive neuro-muscular system diseases. * severe spasticity in the upper limbs. * severe bone, joint, or muscle deformities or lesions. * history of mental illness.
evaluation and comparison of the growth rate of pancreatic cancer patient-derived organoids

Conditions: Pancreas Cancer

Summary: pancreatic ductal adenocarcinoma (pdac) is one of the most aggressive forms of cancer. despite advances in the understanding of the mechanisms underlying pdac pathogenesis, the impact on patient benefit is lagging. as a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics. organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology. 3d organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. in this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle aspirations (fna) and fine needle biopsies (fnb).


Eligibility criteria:
inclusion criteria: * patients with indication for eus-guided fna or fnb of a suspected pancreatic malignancy exclusion criteria: * \< 18 years * patients unable to give consent
iressa as a first-line treatment in chemonaive patients with inoperable non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to assess the overall response rate to iressa as a first-line treatment in chemonaive patients with inoperable non-small cell lung cancer (nsclc)

the epidermal growth factor receptor (egfr) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including nsclc.furthermore, high levels of egfr expression have been associated with a poor prognosis in lung cancer patients in several studies. egfr-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (iressa \[zd1839\]; astrazeneca, wilmington, de). iressa is an orally active, selective egfr tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib/iv nsclc * no immediate need for palliative radiotherapy and no prior chemotherapy * age \> 20 y/o * ecog ps: 0 - 2 * anc \>2000 * plt \>100k * hb \> 10 * total bilirubin \< 2.0 mg/dl * serum creatinine \< 2 mg/dl * sgpt and sgot \< 2.5 ×uln, alkaline phosphatase \< 5 ×uln * life expectancy \>6mos. exclusion criteria: * if the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy * 2nd malignancies * unable to swallow tablets * patients (m/f) with reproductive potential not implementing adequate contraceptive measurements * pregnant or lactating patients * participation in other clinical trials within 30 days of study entry * major systemic disease which in the investigator's opinion might confound the clinical trial

Keywords: egfr non-small cell lung cancer
post-surgical chronic pain after retroperitoneal laparoscopic living kidney donor

Conditions: Chronic Post Operative Pain; Kidney Transplant; Complications; Anesthesia Regional; Laparoscopy

Summary: this study aimed to determine the relationship between the quadratus lumborum and erector spinae plane block technique and the incidence and severity of chronic post-surgical pain in accordance with brief pain inventory score (bpi) in retroperitoneal laparoscopic living kidney donor surgery

a minimum of 130 subjects will be recruited and divided into two groups (65 ql block, 65 esp block). the researcher will use the brief pain inventory (bpi) score to assess the incidence and severity of chronic pain of the living kidney donor who has undergone retroperitoneal laparoscopy with ql or esp block technique

Eligibility criteria:
inclusion criteria: * patient 18-65 years old * patient with asa physical status assessment 1-3 * all patient who have undergone living kidney donor with retroperitoneal laparoscopy at rsupn dr. cipto mangunkusumo (3 months postoperative) * the patient and/ or the family are willing to be interviewed about the patient's previous medical history and agree to be the subject of the study. exclusion criteria: * patient who have already known the cause of the chronic pain they had * patient who have history of major surgery after the donor surgery * patient died during the study
ph-weighted mri in multiple sclerosis: a surrogate marker of tissue metabolic stress

Conditions: Multiple Sclerosis

Summary: twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for this study. mri scans will take place on a 3t mri scanner (skyra or prisma, siemens medical solutions) located at the nyu center for biomedical imaging. mri scans will consist of a 1-hour brain scan for both patients and controls. in the first 6 months of the study, investigators will develop and test a umt-based apt imaging for brain tissue ph measurement and use a hypercapnia paradigm to validate the tissue ph changes between breathing room air and 5% co2 (by increasing tissue acidity) inhalation. with implementation of hypercapnia mri, ph-weighted imaging will be validated for its robustness and reproducibility.

the contrast agent (gd-dtpa, gadavist) will be injected intravenously (iv) in the arm (patients only). the iv will be inserted by qualified medical professional at cbi. this contrast agent will be standard dose in accordance with its fda approved labeling and dosing. controls will not be administered the contrast agent.

Eligibility criteria:
inclusion criteria: * healthy male or female non-ms control volunteers exclusion criteria: * medically unstable or with cardiac, pulmonary, hematological, renal, or hepatic dysfunction. * current or past dsm-iv diagnosis of major depression, bipolar and psychotic disorders. * contraindications for mri, including * intracranial clips * metal implants * external metallic devices/objects/clips within 10mm of the head * suspected or confirmed metal in the eyes (history of welding or similar activity) * claustrophobia * cardiac pacemaker or pacing wires * pregnancy - pregnancy tests will be offered to women of childbearing age at no cost to the subject * history of moderate to severe head injury, stroke, and seizures. * alcoholism or drug dependency. * renal or liver disease as this may cause concerns related to gd-dtpa contrast agent. * allergy to the contrast agent gadolinium * relapses or steroid therapy in patient at or in the month preceding the study * patients only
algorithm to control postprandial, post exercise and night glucose excursions in a portable closed loop format

Conditions: Diabetes Mellitus, Type 1

Summary: in previous studies, we tested the feasibility of a bi-hormonal closed loop system. this system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. glucose control with automated closed loop control was comparable to patient-managed open loop control. the closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. the aim of this trial is to assess the efficacy of the new prototype at the home of the patient. it is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with diabetes mellitus type 1 * treated with insulin pump therapy for a minimum of 6 months * age between 18 and 75 years * willing and able to sign informed consent exclusion criteria: * impaired awareness of hypoglycemia (score ≥ 4) according to gold and/or clarke questionnaire * bmi \> 35 kg/m2 * hba1c \> 97 mmol/mol (=11.0 %) * use of heparin, coumarin derivatives or oral corticosteroids * skin condition prohibiting needle insertion * pregnancy and/or breastfeeding * living alone during the closed loop period (the patient may ask someone to stay over temporarily) * any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results

Keywords: artificial pancreas bi-hormonal closed loop diabetes type 1
behaviour and cognitive evaluation for dialysis elderly patients (bcde)

Conditions: Renal Insufficiency

Summary: the trial is a multicenter, prospective, randomized, open study. a total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.the aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. the hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.


Eligibility criteria:
inclusion criteria: * patients aged of 75 years old or more, * chronic kidney disease stage 5 defined by : * either an estimated gfr (mdrd) ≤ 15ml/mn/1,73 m² in a non-dialysis patient whatever the duration of previous monitoring by the nephrologist("pre-dialysis cohort"), * or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist("post-dialysis cohort"), * signed and dated informed consent. exclusion criteria: * moderately severe to severe dementia (mms ≤ 15), * major depression and/or gds-15 \> 10/15, * severe dependency (adl \< 3/6), * psychosis, mutism or aphasia, * malignancy or any pathology with life expectancy \< one year, * ongoing specialized geriatric care

Keywords: elderly patients renal insufficiency gerontologic evaluation
perinatal arterial stroke: a multi-site rct of intensive infant rehabilitation (i-acquire)

Conditions: Perinatal Stroke; Hemiparesis

Summary: this is a phase iii clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - i-acquire - to usual and customary forms of infant rehabilitation in infants who experienced perinatal arterial stroke (pas).

the proposed study is a phase iii trial powered to determine efficacy of two different doses of i-acquire for children 8 to 36 months old with pas and hemiparesis. the design is a prospective randomized controlled trial (rct) in which 216 children will be randomly assigned to one of 3 treatment groups (n=80 per group): 1) moderate dose i-acquire (3 hrs/day, 5 day/wk x 4 wks), 2) high dose i-acquire (6hrs/day, 5 days/wk x 4 wks), or 3) usual and customary treatment (u\&ct). i-acquire will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; u\&ct will be provided by community therapists with dosage and approaches documented weekly. all primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with pas.

Eligibility criteria:
inclusion criteria: * child will be 8 - 36 months old when study treatment will be delivered * child has a diagnosis of perinatal arterial stroke (pas) * parent permission to provide the child's clinical mri to the study * child has hemiparesis * parent(s) willing to participate in the home therapy component * one parent english language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in english exclusion criteria: * child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health) * child previously received constraint-induced movement therapy (cimt) or modified cimt with a dose of at least 2 hrs/day for ≥10 days * child received botulinum toxin in past 3 months * child is a ward of the state or other agency

Keywords: p-cimt pediatric constraint-induced movement therapy hemiparesis perinatal stroke neonatal stroke pediatric rehabilitation infant therapy cerebral palsy acquire i-acquire
bioequivalence trial of alprazolam 2 mg tablets

Conditions: Anxiety Disorders

Summary: the objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. test product was zamoprax® 2 mg (glaxosmithkline) and reference product tafil® 2 mg (pharmacia \& upjohn). one tablet was the single dosage. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 26 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. healthy, between 18 and 40 years. body mass index between 19 and 27 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) - exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. hospitalization for any cause in the seven months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice one week study beginning up to the las blood sample. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of alcohol abuse. use of products containing tobacco, or excess of nicotine, equivalent to five cigarettes per day. positive pregnancy test or breast-feeidg. special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. evidence of non-cooperative attitude during the study. female volunteers on oral contraceptives. -

Keywords: bioequivalence alprazolam anxiety disorders mexico
selara drug use investigation (regulatory post marketing commitment plan)

Conditions: Hypertension

Summary: to collect the efficacy and safety information of eplerenone on patients with hypertension related to their appropriate use in daily practice.


Eligibility criteria:
inclusion criteria: * male or female patients who are prescribed selara tablet for hypertension. exclusion criteria: * subjects who have been prescribed selara tablet.

Keywords: eplerenone selara hypertension good post-marketing study practice drug use investigation regulatory post marketing commitment plan essence
differential effects of milk proteins on postprandial lipemia in response to a fat-rich meal in type 2 diabetes

Conditions: Postprandial Lipemia; Type 2 Diabetes

Summary: enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. it has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins. the purpose of this study is to compare the effects of the milk proteins casein, whey isolate, whey hydrolysate, and alphalact-albumin on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes exclusion criteria: * liver-, kidney- and/or heart disease * serious hypertension (160/110 mmhg)

Keywords: casein whey postprandial triglyceride free fatty acids retinyl palmitate incretins type 2 diabetes
high dose esomeprazole na for prevention of rebleeding after successful endoscopic therapy of a bleeding peptic ulcer

Conditions: Bleeding Peptic Ulcer

Summary: to describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole na in patients in china with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in

a multi-center, randomised, double-blind, parallel-group phase iii study to assess high dose esomeprazole na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures. * female or male aged =18 years and =70 years. * acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator. * one endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as forrest ia, ib, iia, or iib. photo documentation of the source of bleeding should be provided. * successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff. exclusion criteria: * endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator. * sign of multi pub or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, mallory weiss rifts, ulcus simplex, dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in billroth-resected patients. * need for treatment during the first 7 days of the study with nsaids, cyclooxygenase-2 (cox-2) inhibitors, acetyl salicylic acid (asa) (including low dose) or clopidogrel. * planned treatment with: warfarin (including other vitamin k antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine. * chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.

Keywords: peptic ulcer bleeding prevention of rebleeding successful endoscopic haemostatic therapy